A clinical trial to study immunogenicity and safety of Purified Chick Embryo Cell Culture Rabies Vaccine administered intradermally
- Conditions
- Health Condition 1: Z23- Encounter for immunization
- Registration Number
- CTRI/2010/091/000509
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Applicable
- Sex
- Not specified
- Target Recruitment
- 36
1.Healthy adult volunteers of either gender aged between 18-55 years.
2.If female, not pregnant or lactating at the time of enrolment and not planning pregnancy during the vaccination period.
3.Subjects likely to be available for all visits during follow-up period.
4.Willing to sign Informed consent.
1.Pregnancy & Lactation.
2.Subject has received any type of rabies vaccination in the past.
3.Subject has received any dose of rabies immunoglobulin (human/equine) in the past.
4.Subject suffering from any other illness of whatsoever nature
5.Subject is on steroids or any other immunosuppressants or is known to be HIV positive.
6.Subject is planning for surgery in the next 3 months.
7.Subject is on concomitant antimalarials.
8.Subject with history of allergy to any ingredient of the vaccine.
9.Subject not likely to be available for follow-up.
10.Participation in another clinical trial in the past 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All patients achieving ≥ 0.5 I.U. antibody titre on Day 14, Day 28 & Day 90 will be considered to have developed successful protection by Purified Chick Embryo Rabies Vaccine as per WHO specificationsTimepoint: Day 14, Day 28 & Day 90
- Secondary Outcome Measures
Name Time Method ilTimepoint: Not Applicable